Страна: Нова Зеландия
Език: английски
Източник: Medsafe (Medicines Safety Authority)
Cetirizine hydrochloride 10mg; ;
Teva Pharma (New Zealand) Limited
Cetirizine hydrochloride 10 mg
10 mg
Tablet
Active: Cetirizine hydrochloride 10mg Excipient: Hypromellose Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Pregelatinised maize starch Purified talc Titanium dioxide
Pharmacy only
Glochem Industries Limited
For the relief of: · Nasal and ocular symptoms of seasonal and perennial allergic rhinitis · Symptoms of urticaria and insect bites
Package - Contents - Shelf Life: Blister pack, Clear PVC/Aluminium blister pack - 10 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Clear PVC/Aluminium blister pack - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Clear PVC/Aluminium blister pack (dispensing only) - 100 tablets - 36 months from date of manufacture stored at or below 25°C
2013-11-18
Version 1.1 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Zista, 10 mg, tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg cetirizine hydrochloride. Excipient with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White to off white capsule shaped film coated tablets with breakline on one side and ‘10’ embossed on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cetirizine is indicated for the relief of symptoms associated with seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis. Symptoms treated effectively include sneezing, rhinorrhea, post-nasal discharge, nasal pruritus, ocular pruritus and tearing. Cetirizine is also indicated for the treatment of: • allergic conjunctivitis; • insect bites and the uncomplicated skin manifestations of chronic idiopathic urticaria. It significantly reduces the occurrence, severity and duration of hives and markedly reduces pruritus. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS The recommended initial dose of cetirizine is 5 to 10 mg depending on symptom severity, given as a single daily dose with or without food. The time of administration may be varied to suit individual patient needs. If sufficient response is not obtained, the dose may be increased to the maximum recommended daily dose of 20 mg. _Paediatric population _ CHILDREN AGED 6-12 YEARS Same dose as for adults given as a single or divided dose. CHILDREN AGED 2-6 YEARS The recommended dose of cetirizine is 5 mg (half a tablet) once daily. _Special populations _ USE IN ELDERLY Data does not suggest that the dose needs to be reduced in elderly subjects provided that the renal function is normal. RENAL IMPAIRMENT The dosing intervals must be individualised according to renal function. Version 1.1 2 Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in mL/min is needed. The CLcr (mL/min) may be estimat Прочетете целия документ